BE study requirements (fasting/fed) [Design Issues]

posted by venkata krishna  – India, 2015-01-02 08:45 (4191 d 13:08 ago) – Posting: # 14212
Views: 7,921

Dear All,

In Europe, Rivaroxabn 2.5mg/10mg/15mg/20mg tablets are available
I would like to know whether we should go ahead with BE studies for both the strengths (10 mg and 20 mg) of Rivaroxaban or only fasting study for 20 mg (EU submission).

Request you to help on this for the same.

Regards,
Krishnarao. AV
—
Regards,
krishna

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
134 visitors (0 registered, 134 guests [including 28 identified bots]).
Forum time: 22:54 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5